Author: Marine Dollat

Clinical Project Manager

My client is an innovating, dynamic and growing international medical device company currently expanding their clinical team in Switzerland, Geneva area.

Due to this growth my client is looking for a clinical Project Manager who will be in charge of implementing clinical studies to ensure compliance with the European Medical Device Regulation and its recent updates .

YOUR RESPONSIBILITIES:

  • Manage and successfully completion of clinical research operations in clinical studies
  • Ensure that clinical studies are conducted in accordance with local regulations, GCP regulations, and internal SOPs,
  • Work closely with external partner (ie CROs)
  • Manage CROs and ensure adherence to scope of work within timelines and budget
  • Oversee high quality documentation (ie from study protocol to Clinical Study Report) throughout the clinical study is available
  • Management of clinical study budgets including site agreements/budget
  • Risk management handling
  • Establish co-monitoring visit to ensure monitor performance meets expectation
  • Ensure that all relevant documents are properly archived in the TMF during the study

YOUR PROFILE:

  • Minimum B.Sc. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
  • Minimum of 2 years of experience in clinical operations (from startup to close-out); project management skills
  • Strong communication skills.
  • Quick learner to be autonomous quickly
  • Fluent in English and French

For more details, please contact Marine Dollat at mdollat@axepta.com

Senior Packaging and Medical Device Technology Expert

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a senior packaging and medical device technology expert to provide to lead, design and oversee packaging and medical device technology strategy development.

 

Your responsibilities:

  • Lead and manage technical activities to address complex design, development, operational issues for the preparation and timely delivery of Primary and Secondary Packaging for combination products and topical delivery systems
  • Proposes the strategy for developing human factor engineering program for combination products
  • Contributes to develop early and late phase packaging and medical devices (e.g. delivery system for combination products)
  • Proactively contribute to implement regional regulatory requirements and guidelines that impact packaging and medical device activities in close cooperation with Pharmaceutical Development Expert
  • Interact closely with external partner to ensure selection of packaging and medical devices
  • Contributes to implement, with internal partners and external partners, scientific programs to ensure adequacy of the packaging and medical device solutions: leachable & extractible studies, shipment studies
  • Author, review and/or approve key documents such as development reports, validation reports, and relevant sections of regulatory filings (IND, IMPD, CTD)

 

Your profile:

 

  • PhD in Chemistry, Pharmaceutical Sciences, Pharmacist, MS in Chemical Engineering or closely related to the field with at least 10+ years of relevant experience in pharmaceutical/medical device industry
  • You have excellent knowledge of Established track record of success with combination products development programs
  • You have demonstrated a successful experience with external partners
  • You have excellent knowledge in developing primary and secondary packaging, medical devices
  • You have excellent knowledge of cGMP, 21CFR820, ISO13485, ICH guidance’s, ISO standards and applicable guidelines
  • You have demonstrated a successful experience related CMC sections of IND/IMPD and NDA/CTD/BLA regulatory submissions
  • You speak and write English fluently

 

For more details, please contact Marine Dollat at mdollat@axepta.com

Program Manager – Drug Development

My client is an innovating, dynamic and growing international pharmaceutical company currently

expanding their regulatory team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Program Manager (drug development) to provide day-to-day project management leadership to global drug development project teams. He/she will maintain project plans and budgets, organize and lead project team meetings to meet goals.

YOUR RESPONSIBILITIES:

  • Bring strong expertise product development plans
  • Coordinates global, cross-functional, complex drug development project teams and provides advanced project management support, including action item tracking, organization and communication of materials.
  • Organizes interdepartmental activities to ensure completion of assigned projects within scope, on schedule and within budget constraints.
  • Identifies, monitors, and analyzes business project risks and prepares project planning contingency scenarios.
  • Ensures accurate tracking and reporting of project milestones and deliverables
  •  Identifies and communicates resource constraints to senior management.
  • Prepares project updates for governance meetings and clearly communicates status in written documents and presentations.
  • Ensures documentation of, and access to, key project documents, presentations and data.
  • Assumes full responsibility for managing specific aspects of the project as designated by team leadership

Expected qualifications:

  • Bachelor or PhD degree (MBA)
  • At least ten years of relevant experience in experience in a Biopharma or Biotech environment with and seven years in a similar position in Project Management
  • Thorough understanding of the drug development processes
  • Hands-on expertise with project management tools
  • Good understanding of financial and resource planning systems and processes and ability to coordinate project level budget/resource estimates and manage actuals vs. plan
  • Good communication
  • Fluent in English

For more details, please contact Marine Dollat at mdollat@axepta.com

Regulatory Affairs Submission Associate

My client is an innovating, dynamic and growing international pharmaceutical and consumer care company currently expanding their regulatory team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Regulatory Affairs Submission Associate with good experience in Electronic Document Management System.

In this challenging and dynamic role, you will support the Regulatory Affairs Submissions team in the frame of new registrations and maintenance of the registered products.

Regulatory Affairs Submission Associate

YOUR RESPONSIBILITIES:

  • Coordinate the constitution and/or tracking of registration, variation or renewal dossiers
  • Lead timely receipt and dispatch of administrative documents and their legalization necessary for registration, renewal and variation files 
  • Be an ad-hoc support for European countries
  • Work closely with the regulatory team to lead new registrations and maintenance of the registered products.
  • Support the team in terms of uploading documentation in our EDMS system, put in place tracker for Regulatory Affairs Database update.

 

YOUR PROFILE:

  • BSc in Scientific or equivalent experience with an experience of minimum 1-2 years in regulatory affairs, ideally in global organization for international countries.
  • Experience in a multinational environment
  • Experience in the pharmaceutical industry and use of Electronic Document Management System, regulatory affairs database
  • Fluent in English, Spanish is a plus

Clinical Data Manager

My client is an innovating, dynamic and growing international medical device company currently expanding their clinical team in Switzerland, Geneve Canton.

Due to this growth my client is looking for a Clinical Data Manager.

Your Responsibilities :

 

– Contribute to the definition and the implementation of EDC or paper case record form of clinical studies.

– Be in contact with the global authorities.

– Leverage EDC development outsourced to external partners and manage related activities including setting up of data transfer agreements and appropriate clinical database reconciliation with internal database (ie safety database)

– Act as EDC representative

– Setup and lead clinical trial data and EDC specifications, EDC design, edit checks programming

– Maintain current awareness of regulations, guidance documents (Data Management Plan, Data Validation Plan…), advisory committees, industry standards, appropriate archiving, GCP and interna SOPs.

– Manage user access to the clinical database. Ensure appropriate training is received.

– Work closely with clinical project manager to ensure quality of clinical data throughout the clinical study lifecycle to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review or final database lock.

– Participate in the development and maintenance of Data management SOPs.

 

Your Profile :

– Minimum B.Sc. degree in Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science ;

– Minimum of 4 years of experience in clinical data management.

– Strong knowledge of CDISC standards is required ;

– Experience in biostatistics and/or SAS programming is a plus ;

– Strong critical thinking and problem solving skills ;

– Able to rapidly adapt to changing environment and circumstances ;

– Fluent in English and French.

Senior HCP Marketing Manager

My client is an innovating, dynamic and growing international pharmaceutical and consumer care
company currently expanding their global Marketing team in Switzerland, Vaud Canton.
Due to this growth my client is looking for a Senior HCP Marketing Manager with good experience in
communication with Healthcare car providers especially with skincare.
In this challenging and dynamic role, you will contribute to change the way the world thinks about
skin health by leading the development of Global healthcare professional strategies.
You will play a key role to strengthen the understanding among healthcare professionals on what
skincare products can do to improve the health of the skin of their patients/customers.

Responsibilities:
• Will lead the development of the Global HCP strategy, Global communication campaigns for
healthcare professionals as well as scientific communication to be delivered to markets.
• Will provide expert scientific dermatology knowledge to develop new products as well as
compelling science-based communication messages.
• Deliver knowledge with support and alignment of Medical Expert and Claim Coordinator
(CM): Own the HCP section in the SWOT analysis and in the brand innovation strategy and
implementation, deliver scientific rationale behind consumer concepts and Claims, Integrate
and align scientific inputs from local markets
• Lead the development of the HCP strategy and toolkit (with the input of experts) : manage
agencies from start to finish, Gather inputs from relevant stakeholders throughout the
process, Perform toolkit deployment and train the local Medical affairs or local
representatives, Organize scientific/medical expert meetings with the participation of
Medical Expert and Claim manager
• Set up, leading and delivering scientific communication in partnership with CM and Medical
Expert (posters, publications)
• Member of project team: Provide HCP inputs whenever required and represent Scientific and
Medical voices in the project team. Coordinate cross functional alignment with local Medical
Affairs, Global Clinical Operations, Medical Expert
• Lead and coach global brand manager(s); implement all people related processes
(performance management, talent selection and development, compensation review etc.) to
develop and reward direct reports
• Represent brand with HCPs during congresses, symposiums, etc.

Your profile:
• Nutritionist / Dermatologist / pharmacist background with master in Marketing
• More than 10 years experience in HCP marketing management in the FMCG/FMCH industry
in cosmetics / dermatology and matrix organization at a local ,regional and global level
• Successful track record of working in a matrix organization and managing diverse teams.
• Thought leader in different lifecycles of brands (incl. ideation, launch and sales)
• Thought leader in turning medical concepts / stories & claims into HCP and consumer centric
concepts and claims to help support business initiatives
• Thought leader in building strategies and assets to drive connectivity with target consumers
via HCP influencers (from KOL to pharmacy assistant)
• Combination of consumer centric business acumen and scientific savviness
• Proficiency in English

 

For more details, please contact Marine Dollat at mdollat@axepta.com

Senior Regulatory Affairs Specialist

My client is an innovating and dynamic Medical Device company currently expanding their Regulatory Affairs Team.

Due to this growth my client is looking for a Senior Regulatory Affairs Specialist with a strong FDA experience to join them in Geneva area.

This position will report to the Regulatory Affairs Head.

YOUR RESPONSIBILITIES:

  • This position will be focused on the registration of Class III medical devices, in particular on US and Asian countries:

– Preparation of registration dossiers (ex : technical documentation, PMA and IDE)

– Manage the follow-up of the registration procedures and preparation of responses to Competent Authorities questions

– Assist the team in the Regulatory evaluation of US changes (Change control)

– Manage the maintenance of registration dossiers (modifications and renewals)

  • Define the regulatory strategy in the framework of the development of new products in collaboration with internal departments
  • Prepare and support audits conducted by Notified Bodies and Competent Authorities
  • Be the regulatory affairs representative in the varied project teams
  • Key contact and support for distributeurs
  • Follow-up the regulatory monitoring for medical devices

YOUR PROFILE :

  • Minimum 5 years experience in a regulatory affairs position for medical devices, preferably in international area
  • Be familiar with US FDA regulations
  • Must be able to write clearly and strong analytical thinking (ability to compile data and summarize results)
  • Excellent knowledge of English language
  • Team player and enthusiastic individual, versatile and dynamic
  • Team-oriented personality
  • Ability to work in a dynamic environment
  • A first experience in project management would be a plus

For more details, please contact Marine Dollat at mdollat@axepta.com

Global RA Head

My client is an innovating, dynamic and growing international pharmaceutical company currently

expanding their regulatory team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Global RA Head to manage a team and ensure best regulatory strategy in compliance with local and international regulatory requirements for OTC drugs and more generally consumer products

 

YOUR RESPONSIBILITIES:

 

  • Management of RA submisssion-team and set priorities according business needs and managerial considerations
  • Act as Global regulatory representative Franchise Committee
  • Ensure best regulatory strategy in compliance with requirements
  • Represent the company in Health Authorities‘ meetings
  • Ensure professional development of individuals
  • Act as deputy RA Head upon request
  • Coordinate the writing and update of dossiers according to the current Regulation
  • Ensure regulatory intelligence and initiate modifications of formulations when needed
  • Bring strong expertise in regulatory affairs on cosmetics (EU regulation 1223/2009 but not limited )
  • Work closely with different departments (marketing, safety, toxicology, BD,..)
  • Work closely with external partner

 

 

YOUR PROFILE:                   

  • PhD or Master in Science or equivalent with minimum 15 year experience in a similar position.
  • Prior experience in global Regulatory Affairs including few years in the Consumer Care environment (OTC drugs/Cosmetics/Medical devices).
  • Knowledge and management record of frontier products category.
  • Strong experience in management of a big blockbuster brand across international US and Asia (japan/Korea)
  • Strong experience in team management
  • Strong leadership
  • Fluent in English
  • Mature interpersonal, communication and organizational skills.

 

For more details, please contact Marine Dollat at mdollat@axepta.com

Global RA Senior Manager

My client is an innovating, dynamic and growing international pharmaceutical company currently

expanding their regulatory team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Global RA Senior Manager to manage a team and ensure best regulatory strategy in compliance with local and international regulatory requirements for OTC drugs and more generally consumer products

 

YOUR RESPONSIBILITIES:

 

  • Act as Global regulatory representative of OTC products Franchise Committee
  • Ensure best regulatory strategy in compliance with requirements
  • Represent the company in Health Authorities‘ meetings
  • Act as deputy RA Head upon request
  • Coordinate the writing and update of dossiers according to the current Regulation
  • Ensure regulatory intelligence and initiate modifications of formulations when needed
  • Work closely with different departments (marketing, safety, toxicology, BD,..)
  • Work closely with external partner

 

 

YOUR PROFILE:                   

  • PhD or Master in Science or equivalent with minimum 7 year experience in a similar position.
  • Strong experience in global Regulatory Affairs in the Consumer Care environment (OTC drugs/Cosmetics/Medical devices)
  • Strong experience with external partner
  • Strong experience in team management
  • Fluent in English
  • Mature interpersonal, communication and organizational skills.

 

For more details, please contact Marine Dollat at mdollat@axepta.com

PMS Specialist

My client is an innovating, dynamic and growing international medical device company currently expanding their team in Switzerland, Geneva canton. Due to this growth my client is looking for PMS Specialist to join there regulatory affairs’s team.

YOUR RESPONSIBILITIES:

Act as interface between product surveillance and regulatory, Quality, Clinical R&D, and Marketing team to gather appropriately PMS data.

  • Ensure the interface between the Safety department and other services within the company (R&D, Clinical, Marketing, Regulatory Affairs and Quality)
  • Participate in the development of cross-functional document planning and review meetings
  • In connection to R&D and Clinical team, analyze, adapt and translate technical information related to the products into medical information suitable for the marketing team

Collect, trend and escalate data related to Post marketing Surveillance

  • Develop PMS plans, PMCF plans, PSURs, and PMCF reports
  • Participate to the development of the CER
  • Regulatory watch: PMS, clinical, MD vigilance, Medical Affairs
  • National health authorities website surveillance, including FSA (Field Safety Action)
  • In charge of the Scientific literature intelligence (performance and safety vs competitors)
  • Track competitors data performance (clinical studies) and safety (vigilance)

Ensure that post marketing procedures, processes and documentation meet the regulations in all Teoxane subsidaries

  • Participation in the activities of risk management in connection with the customer complaint process (map, tables and risk management)
  • Develop the risk management process with R&D-CA-RA-MA interfaces, and user table point of contact
  • Participation on various committees (Change Board, CAPA Board, Risk Board, Quality Committee)
  • Follow-up to the NCF, changes and CAPA in connection with medical affairs
  • Participation in the improvement of processes, procedures, instructions, forms, tools and database in relation to the activities of the Medical Affairs Department
  • Participation to Audits

YOUR PROFILE:

  • Master in regulatory affairs or equivalent with minimum 3/5 years experience in a similar position
  • Strong knowledge with medical devices 
  • Strong knowledge with QSM and risk management
  • Fluent in  English (speak and write)

For more details, please contact Marine Dollat at mdollat@axepta.com

Senior Expert Drug Design

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton. Due to this growth my client is looking for Senior Expert Drug Design to contribute for the design and evaluation of future oral and topical drug.

 

YOUR RESPONSABILITIES:

 

  • Contributes to the implementation of the future Drug Design strategy axes and ensure the strategy for outsourcing choices (CRO, university,..) that best correspond to strategic choices.
  • Participates to the evaluation and prioritization of projects
  • Ensures the implementation of partnerships and technological solutions 
  • Leads to the design and evaluation of innovative molecules for future drug candidates in collaboration with CROs, for oral and topical projects.
  • Leads collaboration with CRO partners for all design components of future drug candidates for portfolio projects.
  • Ensures to maximizing the value proposition of Research and Development projects.
  • Contributes to maintain an innovative and competitive research project portfolio
  • Contributes to the management of the global research budget of SIG Rx.
  • Contributes to the visibility of the company at international level (conferences, collaborations, KOL etc. …).


YOUR PROFILE:

  • PhD in Organic Chemistry or PhD in Medicinal Chemistry with minimum 10 years experience in Drug Design
  • Strong knowledge in biology, pharmacokinetics, silico modelling techniques, the drug discovery process and team management.
  • You have demonstrated an experience of innovation and significant achievement in the field of Drug Design as well as in the field of systemic, oral or injectable medicines.
  • You have conducted collaborative research programs with external partners.
  • You have good knowledge of fields biology/therapy areas and pathologies.
  • You have good knowledge of the development processes and early clinical development in particular
  • Excellent teaching and presentation skills are expected, as well as an excellent leadership capacity with a multicultural and multidisciplinary team.
  • You have gained international recognition for your work (conferences, publications, patents).
  • You speak and write English fluently.

 

For more details, please contact Marine Dollat at mdollat@axepta.com

Senior Safety Advisor Cosmetics

My client is an innovating, dynamic and growing international pharmaceutical company in Switzerland, Vaud Canton. Due to this growth my client is looking for Senior Safety Advisor cosmetics to lead activities of safety and toxicology aspects for raw materials and finished products.

Senior Safety Advisor Cosmetics

YOUR RESPONSABILITIES:

Safety of raw materials:

    • Release safety certificate of raw materials for Development
    • Provide toxicological data of new raw materials
    • Management raw material data to support reg dossier (Safety parts, INCI)
    • Support Vigilance group, global customer service and project teams on safety and innovation support
    • Manage expertise for ingredients/products in terms of production issues
  • Leader to deliver Safety assessment of bulk/finished products and/or participate when contracted out and calculate safety margin of all ingredients per formula
  • Provide support for first assessment of a new cosmetic formula
  • Observe and give update of legislation changes regarding raw material and ingredients
  • Manage all outsourced activities within domain of expertise
  • Write safety section of dossier and defend product with Agencies as needed
  • Organize a Data base on safety ingredients for the unit
  • Establish KPIs and Track / monitors the performance to improve them further
  • Support all activities related to Safety in liaison with Claims Development and Product Development and provide necessary expertise and support decision globally in this field

YOUR PROFILE:

  • PhD master in toxicology /chemistry / pharmacy or equivalent with minimum 10 years’ experience in Safety assessment
  • Strong experience in cosmetics
  • Strong experience with safety and toxicology aspects.
  • Proof of safety assessor courses including certificates
  • Proven record of experience in safety assessments of ingredients and cosmetic products marked WW
  • Strong leadership skills
  • Excellent oral and written communication skills
  • Strong communication skills;
  • Expert level oral and written English

For more details, please contact Marine Dollat at mdollat@axepta.com

Medical Writer

My client is an innovating, dynamic and growing international medical device company currently expanding their clinical team in Switzerland, Geneve Canton.

Due to this growth my client is looking for a Medical/Scientific Writer.

The position will report to the Head of Clinical Development Department.

 

Your Responsabilities :

       Prepares and finalises clinical documents such as, but not limited to, CSRs and appendices, IBs, protocols and protocol amendments, summary documents, RMPs (initial and updates), regulatory responses, and briefing documents. Documents must be of high quality in terms of scientific content, as well as organisation per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency;

       Leads cross-functional document planning and review meetings

       Leads in a team environment with greater independence for longer-term activities, and takes a lead role on assigned projects concerning timing, scheduling, and tracking;

       Indirectly or directly leads or sets objectives for others on team projects and tasks; e.g., able to lead process working groups;

       The primary point of contact for Clinical Development Team for medical writing activities;

       Responsible for functional planning and metrics database updates for assigned program.

 

Ihr Profil :

       PhD or Master in elated Pharmaceutical Science with minimum 3 years experience of relevant regulatory medical writing

       Ability to function (and potentially lead) in a team environment;

       Demonstrates learning agility ;

       Builds solid and productive relationships with cross-functional team members;

       Strong project management skills

       Strong leadership skills

       Fluent in English and French